Ultrasound Based Transperineal Robotic Biopsy of the the Prostate (BxB)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01102361
First received: April 11, 2010
Last updated: April 12, 2010
Last verified: May 2006
  Purpose

The objective of the study is to examine the effectiveness and accuracy of the BioXbot in prostate biopsy as opposed to transrectal biopsy. This evaluation of the efficacy of both the procedures is based on:

  • Uptake rate
  • Peripheral zone reachability
  • Needling accuracy
  • Procedure execution time
  • Post operative discomfort or trauma experienced by patient
  • Quality and type of tissue sample extracted
  • Adverse and unanticipated side-effects on patient after the procedure and recording any unexpected reactions

Condition Intervention Phase
Previous Negative Biopsy
Procedure: Robotic Transperineal Biopsy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of Prostate Cancer Detection With in House Developed Robot

Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Cancer Detection [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    to detect any undetected cancer in Patietns undergoing saturation biopsy


Secondary Outcome Measures:
  • Accuracy and Repeatability [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To be accurate in biopsy position (+/- 2mm) and be able to go back to the same position if patient undergoes treatment.


Estimated Enrollment: 250
Study Start Date: May 2006
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transperineal Biopsy
Biopsy of the prostate using transperineal approach
Procedure: Robotic Transperineal Biopsy
Saturation biopsy for previous negative patients

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one normal previous prostate biopsy and at least 2 weeks since prior prostate biopsy
  • Increasing prostate-specific antigen (PSA) level
  • The Investigator has completed a medical history and a physical examination to assure that the subjects meet all study enrollment criteria

Exclusion Criteria:

  • Patient with operative risk ASA ( American Society of Anaesthesia) = or > 4
  • A history of bleeding disorders/coagulopathy or ongoing treatment for this condition
  • Patients with psychiatric diseases or insufficient cerebral function
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102361

Contacts
Contact: Henry Ho, Doctor ho.henry.s.s@gmail.com
Contact: Preeti Mohan, Biomedical Engineer preeti.mohan@gmail.com

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Henry Ho, Doctor       ho.henry.s.s@gmail.com   
Contact: Preeti Mohan       preeti.mohan@gmail.com   
Principal Investigator: Christoper Cheng         
Sub-Investigator: Henry Ho         
Sub-Investigator: John Yuen         
Sponsors and Collaborators
Singapore General Hospital
  More Information

No publications provided

Responsible Party: Prof. Chris Cheng, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01102361     History of Changes
Other Study ID Numbers: BioXbot
Study First Received: April 11, 2010
Last Updated: April 12, 2010
Health Authority: Singapore: Health Sciences Authority

ClinicalTrials.gov processed this record on October 21, 2014